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"Agomelatin in chronic low back pain"

Comparing The Analgesic Effect Of Agomelatin Versus Placebo In Combination With Pregabalin In Patients With Chronic Low Back Pain : A Randomized , Double-Blinded Study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200620047852N1
Enrollment
84
Registered
2020-06-23
Start date
2020-07-06
Completion date
Unknown
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic low back pain. Low back pain

Interventions

Intervention 1: Intervention group: we will prescribe Pregabalin 75mg BD + Agomelatin25mg once a day.Before starting Agomelatin and in the 3rd week we will check Liver enzymes. PATIENTS WILL BE EVALUA

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients with chronic low back pain without an indication for surgery.Chronic low back pain+patients with low back pain for at least 3 months(almost everyday) Patients aged between 18 to 60

Exclusion criteria

Exclusion criteria: Patiens with long term usage of Opioids , Anti depressants , Benzodiazepines,Gabaergic drugs Any contraindications for using each drugs(Agomelatin or Pregabalin) Liver enzymes three times more than normal Patients with depression disorder or suicidal thoughts or psychosis or acute manic phase or cognitive disorder or anxiety disorder or PTSD who needs treatment. These patients will exclude by an interview done by an educated psycholoy resident due to DSM5 Patients who need surgery will exclude PAtients who are taling any Anti-depressants drugs Patients who took Pregabalin within 1 month Patients who are taking physiotherapy courses will exclude Life expectancy under 12 month Patients who are pregnant or during breastfeeding period

Design outcomes

Primary

MeasureTime frame
Score of pain in brief pain inventory scale (BPI) questionnaire. Timepoint: The beginning of the the study and 1st,4th,8th week. Method of measurement: Brief pain inventory scale (BPI) questionnaire.

Secondary

MeasureTime frame
Roland-Morris Disability Questionnaire (RMDQ). Timepoint: The beginning of the study and 1st,4th,8th week. Method of measurement: Roland-Morris Disability Questionnaire (RMDQ).;Score of anxiety and depression by The Hospital Anxiety and Depression Scale (HADS). Timepoint: The beginning of the study and 1st,4th,8th week. Method of measurement: Roland-Morris Disability Questionnaire (RMDQ).;Evaluating the health and function of the patients using SF-36 questionnaire. Timepoint: The beginning of the study and 1st,4th,8th week. Method of measurement: SF-36 questionnaire.;Evaluating the psychologic status of the patients using GHQ-28 questionnaire. Timepoint: The beginning of the study and 1st,4th,8th week. Method of measurement: GHQ-28 questionnaire.;Evaluating the demographic variables using the questionnaire designed by the researcher. Timepoint: The beginning of the study and 1st,4th,8th week. Method of measurement: Questionnaire designed by researcher.;Evaluating the drugs complications by drug checklist designed by researcher. Timepoint: The beginning of the study and 1st,4th,8th week. Method of measurement: drug check list designed by the researcher.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShayan Amiri

Iran University of Medical Sciences

Amiri.shayan23@gmail.com+98 21 2236 3375

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 13, 2026